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Phase 2 Completed N=60 Randomized Treatment

Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients

Source: ClinicalTrials.gov NCT00469209 ↗
Enrolled (actual)
60
Serious AEs
11.7%
Results posted
Apr 2011
Primary outcomePrimary: Number of Patients Reaching Complete Response (CR) — 4; 1; 4 participants

Summary

Primary Objectives: 1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma 2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma 3. To determine the effects of bortezomib on melphalan pharmacokinetics

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients Reaching Complete Response (CR)
4; 1; 4
SECONDARY
Time to Toxicity

Eligibility Criteria

Inclusion Criteria

  • a) Primary Refractory Disease (defined as failure to achieve even a partial response to induction therapy) b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) Relapsing after prior therapy (disease relapsing after achieving a partial or complete response to prior conventional or high-dose therapy).
  • Age up to 75 years.
  • Zubrod performance status of 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
  • Forced expiratory volume (FEV1), forced volume vital capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >40%. No symptomatic pulmonary disease.
  • Serum bilirubin 1L prior to drainage.
  • HIV-negative.
  • Negative Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
  • Patient or guardian able to sign informed consent
  • Corrected QT interval less than 470 msec.

Exclusion Criteria

  • Corrected QT interval greater than 470 msec.
  • Patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
  • Patients with non-secretory myeloma.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00469209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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